39 Manufacturing Technicians jobs in Pittsburgh

Position Title: Quality Control/Testing: II

Work Location: Durham (Rodolphe)

Assignment Duration: 6 Months

Work Schedule: NIGHT 12 HR (15%) (Wknd 15%)

Work Arrangement: Onsite

Position Summary: The QC Biochemistry Analyst 2 role is responsible for routine Biochemistry testing.

Background & Context:

• This position is in a fast-paced, FDA-regulated environment in the Medical Devices/Diagnostics Industry.

• The QC Biochemistry Analyst 2 will be in a key position in the Biochemistry laboratory performing testing of Description, pH, FTIR, Osmolality, Moisture Analysis, Solubility, Loss on Drying, Resin Ratio, Reflectance, and pO2 Headspace Analysis, HPLC.

Key Responsibilities:

• Testing of raw materials, intermediates, special test requests, and finished product samples per standard operating procedures.

• Investigational writing of INVALID reports.

• Provide input and support for Out of Specification reports.

• Serve as a certified trainer for laboratory testing as applicable.

• Leads as trainer for Quality Control testing and instrument maintenance.

• Troubleshoots simple to moderate Biochemistry laboratory equipment-related issues.

• Ensures all testing documentation is completed in an accurate, thorough, and timely manner. Documents test results in compliance with procedures and GDP requirements.

• Ensures review of laboratory testing is done in compliance with SOPs and is completed in a timely manner. • Maintains compliance with SOPs, GLP, GMP, and HSE requirements.

• Prepares for regulatory, customer, and internal audits of Biochemistry laboratory areas.

• Preparation includes review of logbooks for completion, instrument calibration checks, checking material expirations, and general cleanliness of laboratory area.

• Executes laboratory investigations as assigned by management in compliance with procedures.

• Provides input for laboratory investigations and documents invalid test results in compliance with procedures.

• Enters data into the laboratory information management system (LIMS) and applicable paper-based data sheets. Assists with LIMS data entry to support LIMS maintenance and validation activities.

• Assists with revisions to QC department standard operating procedures (SOPs) as directed by management.

• Ensures personal training is maintained to current department processes and procedures.

• Trains teammates on Biochemistry laboratory testing and procedures.

• Obtains status as a certified trainer for applicable laboratory testing processes.

• Appropriately utilizes PPE (Personal Protective Equipment) as required to perform routine and non-routine laboratory duties.

• Participate in continuous improvement activities.

• Participate in improvement initiatives as directed by management.

• 6S: Maintain the laboratory and other specific testing areas of responsibility in a well-organized, clean, and tidy manner at all times, in compliance with cGLP.

• Work with other departments and assist with executing validation protocols associated with Biochemistry laboratory equipment, associated software, and procedures, including revalidation as scheduled or required to maintain systems in a validated state.

• Performs additional job-related duties as assigned by management.

Qualification & Experience:

• BS/BA in Biology, Chemistry or Biochemistry.

• In lieu of a Bachelor’s Degree, a high school diploma/GED with a minimum of ≥ 6 years of experience and/or an Associate’s Degree with a minimum of ≥ 4 years of experience working in a regulated laboratory environment, Biochemistry or Chemistry is highly preferred.

• BS with minimum 2 years of experience, or a Master’s degree or PhD with 0 years of experience, in a regulated laboratory environment, Chemistry or Biochemistry is highly preferred.

• Technical and scientific knowledge working with relevant chemistry or biochemistry laboratory techniques and quality principles (GMP/GLP).

• Experience in the use of software tools for data entry and analysis (LIMS); advanced technical writing skills.

• In depth knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, UL, CSA, VDE, etc.).

• Experience participating in the management of regulatory audits (i.e. FDA, MDSAP, ISO, OSHA, EPA, etc.).

• Experience with chemistry or biochemistry testing, knowledge of USP and EP/BP method/validation regulations.

• Experience with applicable instrumentation and troubleshooting.

• Strong organizational skills, the ability to prioritize work and manage multiple tasks independently.

• Excellent and effective verbal and written communication skills.

• Proven ability to problem solve/troubleshoot and provide solutions under minimal supervision.

• Good leadership and communication skills; Teamwork orientation.

• Ability to read, understand, and execute standard operating procedures related to the assigned area of responsibility.

• Able to assess safety and environmental risks to ensuring tasks adhere to HSE Management System.

Title: Quality Control Water Testing Technician

Client: Large Pharmaceutical Manufacturing Company

Type: 6-month contract, possibility of extension or full-time conversion

Location: Durham, NC 27709

Schedule: 2 shift options: 10 hour shifts, one will be Sunday-Wednesday, the other Wednesday-Saturday. 8AM-6PM.

Start date: ASAP

Job Description:

The QC Expert Technician will provide support for the Parenteral Operations by performing accurate and timely testing of utility samples in accordance with appropriate GMP and safety guidelines. The QC Expert Technician is also responsible for performing microbial enumeration and data review activities as required.

Duties:

• Accurately and safely perform microbiological and chemical testing of water samples, clean steam, and compressed gases per established testing procedures and protocols.
• Accurately record data in reports or LIMS in accordance with laboratory procedures, standards, and GMP requirements.
• Recognizes deviations from procedures, methods, etc. and initiates an investigation as required.
• Perform technical review of analytical data, as required.
• Adhere to all Health, Safety, and Environmental standards.
• Identify and communicate opportunities for improvement initiatives in daily work activities.
• Troubleshoot equipment and methods, as required.
• Support lean lab and 5S initiatives.
• Provide technical support for investigations.
• Maintain inventory of all supplies and consumables for the laboratory.

Requirements:

• High School Diploma or equivalent, Associate’s degree is preferred.
• At least one year of experience working within a GMP microbiology laboratory.

Preferred Requirements:

• Experience with electronic laboratory management systems (E.g., LIMS, LES, ELN, MODA)
• Laboratory experience with various microbiological techniques and instrumentation (E.g., Aseptic Techniques, Conductivity, TOC, Endotoxin, Bioburden, Microbial Enumeration).
• Experience in operational excellence, such as lean and 5S initiatives.

Additional Information:

• 8-hour days – Monday through Friday, with weekend support as needed in support of a 24/7 manufacturing operation.
• Minimal travel required.
• Ability to work in various areas within the site. Some allergens are present in the parenteral plant.
• Tasks may require repetitive motion (e.g., keyboarding).

• Working collaboratively with Quality and Quality Assurance teams to author and own change control records and deviations in the DQMS Veeva System
• Individuals will lead investigation teams and help to collect and report metrics for the systems team
• Individuals may assist with a review of validation documents to support equipment and computerized system onboarding.
• Individuals may author, revise and review documents and reports including but not limited to SOPs, test methods, safety assessments, trend reports, qualification/validation summary reports, technical reports.
• Support the startup of a GMP QC laboratory.
• Support routine activities over the weekends and public holidays as required.

• Deviation and Change control writing experience
• Veeva system experience
• Leadership capabilities - must be able to lead meetings, drive investigations.
• The hiring manager is focused on practical aptitude and writing skills. Strong writing and grammar skills.
• Collaborative and proactive.

• Develop, implement, and maintain quality control systems and procedures in accordance with industry standards (e.g., ISO 9001).
• Oversee incoming material inspection, in-process quality checks, and final product testing.
• Utilize statistical methods, such as SPC, to monitor and control manufacturing processes.
• Conduct root cause analysis (RCA) for quality issues and implement effective corrective and preventive actions (CAPA).
• Collaborate with production, engineering, and R&D teams to identify and resolve quality-related problems.
• Develop and implement quality training programs for production and quality personnel.
• Prepare detailed quality reports, including inspection results, trend analysis, and performance metrics.
• Participate in internal and external audits, ensuring compliance with quality standards.
• Manage and maintain calibration records for all quality control equipment.
• Contribute to the continuous improvement of manufacturing processes and product quality through data-driven insights.
• Stay current with quality control methodologies, tools, and technologies.

• Bachelor's degree in Engineering (e.g., Mechanical, Industrial, Manufacturing), or a related technical field.
• A minimum of 5 years of experience in quality control or quality assurance within a manufacturing environment.
• Strong understanding of quality management systems (ISO 9001).
• Proficiency in statistical process control (SPC) and other quality tools (e.g., FMEA, DOE).
• Experience with root cause analysis and CAPA implementation.
• Excellent analytical and problem-solving skills.
• Strong written and verbal communication skills, with the ability to document processes and present findings effectively.
• Ability to work independently and collaboratively within a team.
• Proficiency in relevant software, including MS Office Suite and quality management software.
• Experience in the specific manufacturing sector of our client is a plus.